Clinical Trials /

Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor in Patients With Advanced Solid Tumor

NCT04648254

Description:

This is a Phase 1, open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study with cohort expansion at the RP2D to evaluate safety and anti- tumor activity of Q702 administered orally.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor in Patients With Advanced Solid Tumor
  • Official Title: A Phase 1, Multicenter, Open-label, Dose- Escalation, Safety, Pharmacodynamic, Pharmacokinetic Study of Q702 With a Cohort Expansion at the RP2D in Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: Q702-ONC-P1-US001
  • NCT ID: NCT04648254

Conditions

  • Solid Tumor
  • Advanced Cancer
  • Metastatic Cancer

Interventions

DrugSynonymsArms
Q702Dose escalation (Q702)

Purpose

This is a Phase 1, open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study with cohort expansion at the RP2D to evaluate safety and anti- tumor activity of Q702 administered orally.

Trial Arms

NameTypeDescriptionInterventions
Dose escalation (Q702)ExperimentalParticipants will receive escalating doses of Q702
  • Q702

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with histologically or cytologically confirmed advanced or metastatic solid
             tumors, that have progressed following standard of care therapy or for which there is
             no standard therapy which confers clinical benefit

          -  Measurable disease per RECIST v 1.1

          -  ECOG performance status 0 or 1

          -  Life expectancy of at least 3 months

          -  Age ≥ 18 years

          -  Signed, written IRB-approved informed consent form

        Exclusion Criteria:

          -  New York Heart Association Class III or IV cardiac disease, or myocardial infarction,
             severe unstable angina, coronary/peripheral artery bypass graft, congestive heart
             failure within the past 6 months

          -  Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of >470
             msec (females) and >450 msec (males)

          -  Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic
             therapy

          -  Active, poorly controlled autoimmune or inflammatory diseases
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum tolerated dose (MTD), the dose limiting toxicities (DLT) and the safety profile of Q702
Time Frame:28 days of cycle 1
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Change in the area under curve (AUC) of Q702
Time Frame:Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22
Safety Issue:
Description:
Measure:Change in the maximum plasma concentration (Cmax) of Q702
Time Frame:Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22
Safety Issue:
Description:
Measure:Change in the time of maximum plasma concentration (Tmax) of Q702
Time Frame:Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22
Safety Issue:
Description:
Measure:Tumor response using RECIST version 1.1 throughout study
Time Frame:Baseline up to approximately 2 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Qurient Co., Ltd.

Last Updated

December 1, 2020